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1.1. Adults

Direct acting antivirals (DAA) for hepatitis are FDA-indicated for treatment of chronic infections caused by hepatitis C virus (HCV). Individual agents have varying FDA indications and treatment durations based on genotype (1-6), subtype (1a vs. 1b), liver function, HIV co-infection and/or previous treatment history1.

Table 1 provides DAA information for treatment naïve patients with or without cirrhosis.

Table 1: DAAs for treatment of adult chronic HCV infection: Treatment naïve and patients with or without cirrhosis2-12
Drug NameDosage Form/StrengthTreatment IndicationDuration and CoadministrationMaximum Recommended Dosage
elbasvir/ grazoprevir (Zepatier)50 mg/100 mg tablet

Chronic HCV treatment:

  • genotypes 1a 
    • without cirrhosis or with compensated cirrhosis (Child-Pugh A) with baseline NS5A polymorphisms
16 weeks with ribavirin50 mg elbasvir and 100 mg grazoprevir once daily
  
  • without cirrhosis or with compensated cirrhosis (Child-Pugh A) without baseline NS5A polymorphisms
12 weeks 
  
  • genotype 1b without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks 
  
  • genotype 4 without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks 
glecaprevir/pibrentasvir (Mavyret)100 mg/40 mg tablets

Chronic HCV treatment:

  • genotypes 1, 2, 3, 4, 5, and 6 without cirrhosis or with compensated cirrhosis (Child-Pugh A)    
8 weeksthree tablets once daily (300 mg glecaprevir and 120 mg pibrentasvir)
ledipasvir/ sofosbuvir (Harvoni, generics)90 mg/400 mg tablet

Chronic HCV treatment:

  • genotype 1
    • without cirrhosis
8* weeks or 12 weeks90 mg ledipasvir and 400 mg sofosbuvir once daily
  
  • with compensated cirrhosis (Child-Pugh A)
12 weeks 
  
  • decompensated  cirrhosis (Child-Pugh B and C)
12 weeks plus ribavirin     
  
  • liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks plus ribavirin 
  

genotype 4

  • liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks plus ribavirin 
  
  • genotypes 4, 5, or 6 without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks 
sofosbuvir/ velpatasvir (Epclusa, generics)400 mg/100 mg tablets

Chronic HCV treatment:

  • genotypes 1, 2, 3, 4, 5, and 6 without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks400 mg sofosbuvir and 100 mg velpatasvir once daily
  
  • genotypes 1, 2, 3, 4, 5, and 6 with decompensated cirrhosis (Child-Pugh B or C)
12 weeks plus ribavirin 
sofosbuvir (Sovaldi)400 mg tablet

Chronic HCV treatment:

  • genotypes 1 and 4 without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks plus ribavirin and peginterferon400 mg once daily
  
  • genotype 2 without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks plus ribavirin 
  
  • genotype 3 without cirrhosis or with compensated cirrhosis (Child-Pugh A)
24 weeks plus ribavirin 

Legend:

  • HCV = hepatitis C virus;
  • NS5A inhibitors = Nonstructural protein 5A (NS5A) inhibitors
  • NS3/4A protease inhibitors = Nonstructural protein 3/4A protease inhibitors
  • * = 8 weeks of treatment can be considered in treatment naïve genotype 1 patients without cirrhosis who have pretreatment HCV RNA less than 6 million IU/mL
Table 2: DAAs for treatment of adult chronic HCV Infection: Treatment experienced patients with or without cirrhosis2-12
Drug NameDosage Form/StrengthTreatment IndicationDuration and CoadministrationMaximum Recommended Dosage
elbasvir/grazoprevir (Zepatier)50 mg/100 mg tablet

Chronic HCV treatment:

  • genotypes 1a:
    • that is peginterferon alfa/ribavirin experienced without baseline NS5A polymorphisms without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks50 mg elbasvir and 100 mg grazoprevir once daily
  
  • that is peginterferon alfa/ribavirin experienced with baseline NS5A polymorphisms without cirrhosis or with compensated cirrhosis (Child-Pugh A)
16 weeks plus ribavirin 
  
  • that is peginterferon alfa/ribavirin and/or NS3/4A protease experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks plus ribavirin 
  

genotype 1b:

  • that is peginterferon alfa/ribavirin experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks 
  
  • that is peginterferon alfa/ribavirin and/or NS3/4A protease experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks plus ribavirin 
  
  • genotype 4 that is peginterferon alfa/ribavirin experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
16 weeks plus ribavirin 
glecaprevir/ pibrentasvir (Mavyret)100 mg/40 mg tablets

Chronic HCV treatment:

  • genotype 1
    • who have previously been treated with a regimen containing an HCV NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor with or without compensated cirrhosis (Child-Pugh A) 
16 weeksthree tablets once daily (300 mg glecaprevir and 120 mg pibrentasvir)
  
  • who have previously been treated with a regimen containing an NS3/4A protease inhibitor without prior treatment with a NS5A inhibitor with or without compensated cirrhosis (Child-Pugh A)
12 weeks 
  
  • genotypes 1,2, 4, 5, or 6 with prior treatment with a peg interferon, ribavirin and/or sofosbuvir, but no prior treatment with an NS3/4A PI or NS5A inhibitor without cirrhosis
8 weeks 
  
  • genotypes 1,2, 4, 5, or 6 with prior treatment with a peg interferon, ribavirin and/or sofosbuvir, but no prior treatment with an NS3/4A PI or NS5A inhibitor with compensated cirrhosis (Child-Pugh A)
12 weeks 
  
  • genotype 3 with prior treatment with a peg interferon, ribavirin and/or sofosbuvir, but no prior treatment with an NS3/4A PI or NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A)
16 weeks 
ledipasvir/sofosbuvir (Harvoni, generics)90 mg/400 mg tablet

Chronic HCV treatment:

  • genotype 1 who have failed peginterferon alfa or ribavirin-based regimen with or without a protease inhibitor
    • without cirrhosis
12 weeks90 mg ledipasvir and 400 mg sofosbuvir once daily
  
  • with compensated cirrhosis (Child-Pugh A)
24 weeks or 12 weeks in combination with ribavirin† 
  
  • decompensated cirrhosis (Child-Pugh B or C) plus ribavirin
12 weeks plus ribavirin 
  
  • liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks plus ribavirin     
  
  • genotype 4 who have failed peginterferon alfa or ribavirin-based regimen with or without a protease inhibitor
    • in liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks plus ribavirin     
  
  • genotype 4, 5, or 6 without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have failed peginterferon alfa and/or ribavirin-based regimen with or without a protease inhibitor
12 weeks 
sofosbuvir/velpatasvir (Epclusa, generics)400 mg/100 mg tablets

Chronic HCV treatment:

  • genotype 1, 2, 3, 4, 5, or 6 treated with peginterferon/ribavirin and/or NS3/4A protease inhibitor
    • without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks400 mg sofosbuvir and 100 mg velpatasvir once daily
  
  • with decompensated cirrhosis (Child-Pugh B or C)
12 weeks plus ribavirin 
sofosbuvir (Sovaldi)400 mg tablet

Chronic HCV treatment:

  • genotype 2 previously treated with an interferon-based regimen without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks plus ribavirin400 mg once daily
  
  • genotypes 1a or 3 previously treated with sofosbuvir without a NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A)
24 weeks plus ribavirin 
sofosbuvir, velpatasvir, and voxilaprevir (Vosevi)400 mg/100 mg/100 mg

Chronic HCV treatment:

  • genotypes 1, 2, 3, 4, 5, or 6 previously treated with an NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A)
12 weeks400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir once daily
  
  • genotypes 1a or 3 previously treated with sofosbuvir without a NS5A inhibitor
12 weeks 

Legend:

  • HCV = hepatitis C virus
  • NS5A inhibitors = Nonstructural protein 5A (NS5A) inhibitors
  • NS3/4A protease inhibitors = Nonstructural protein 3/4A protease inhibitors
  • ∆ NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93. Testing prior to the initiation of therapy, subsection NS5A resistance testing in HCV genotype 1a-infected patients
  • £ The optimal ZEPATIER-based treatment regimen and duration of therapy for PegIFN/RBV/PI-experienced genotype 1a-infected patients with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, and 93 has not been established
  • †Harvoni + ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin